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Senior Regulatory Expert

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Regulatory Affairs Professional

We are seeking a highly skilled and experienced Regulatory Affairs professional to join our team in Bengaluru, India.

The ideal candidate will have hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions.

  • Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets.
  • Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, and Africa.
  • Support product registrations, renewals & variations.
  • Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management.
  • Respond to health authority queries in coordination with CMC, clinical, and quality teams.
  • Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines.
  • Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc.
  • Familiarity with GCC-CTD, ASEAN CTD, and regional WHO biosimilar guidelines.
  • Experience working with local affiliates or partner companies in Emerging Markets.
  • Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc.
  • Experience with regional electronic submission platforms.